LivaNova Heater-Cooler Device

What is the LivaNova Heater Cooler device?

Heater-cooler devices are typically used during surgical and medical procedures that require the patient’s temperature to remain at a consistent level. The LivaNova heater-cooler — also known as the Sorin 3T Heater-Cooler — is a compressor-based system which uses three different water tanks to provide adjustable temperature settings.

Initially popular with medical professionals originally, concerns about polluted water along with the transmission of germs to patients utilizing the LivaNova system have prompted a much more serious approach since late 2015.

How do surgeons use the device?

Heater-coolers are primarily used for cardiothoracic surgeries, serving to cool or warm the patient at crucial moments throughout the surgery.

Every year in the U.S, nearly 100,000 heart bypass surgeries are using LivaNova heater-cooler. This makes the device an significant part of open heart operation throughout the country.  By extension, the related risks of this device are also important to think about.

What are the risks of the LivaNova Heater-Cooler?

Because heater-cooler devices use water to vary their temperature, the risk of contamination exists in the water tank. 

Patients don’t have to come into direct contact with the device’s water to be infected.

The LivaNova heater-cooler is not fully water proof and doesn’t use airtight seals.  Because of this, bacteria could be released into the air from the device’s exhaust vent.  With the patient in close proximity and particularly prone to bacterial disease, the contaminated water may indirectly work its way into their system.

Using a contaminated heater-cooler unit presents the risk of serious bacterial infection to the patient, the symptoms of which include:

  • Aching joints and muscle pain,
  • Weight loss,
  • Lethargy or fatigue,
  • Loss of sleep and excessive sweating at night,
  • Unexplained fever.

These health issues arise from the transmission of nontuberculous mycobacteria (NTM). As the symptoms of the condition can vary, so can their seriousness.  Many patients take months to experience these problems, yet the most distressing cases of contamination have caused severe injury and even death.

The dangers of Nontuberculous Mycobacteria (NTM)

Even Though it isn’t contagious to other, there are several risks of NTM for individual patients who have been exposed to contaminated heater-coolers.

Since the bacteria is a slow-growing organism, first symptoms might not be evident for couple of months.  In some cases, over a year has before a patient’s subsequent illness was tracked right back to some contaminated LivaNova heater-cooler unit.

The longer the period that passes after surgery, the harder it can be to treat the following health problems.

As awareness of the heater-cooler risks increases, new cases – and warnings of potential infection – are coming to light. At the end of 2016 several Indiana hospitals sent warnings to patients who had received heart surgery over the previous five years. In that case alone, thousands of patients will be alerted to potential infections, symptoms, and the dangers of NTM.

LivaNova Heater-Cooler Lawsuits

As contaminated heater-coolers are a relatively recent complaint first alerted in overdue 2015 — legal action against LivaNova and Sorin remains in its initial phase.  People have filed lawsuits based on their health complaints related to heater-cooler assisted surgery, but there’s currently no class action lawsuit against the device and its makers.

One of the first heater-cooler lawsuits was filed in Pennsylvania when a man from York passed away after undergoing open heart surgery in 2014.  David Inners lived with the heater-cooler associated infection for almost one year after the procedure, he was 62 when he passed away.  Another 11 patients came down with similar symptoms at the same time as Mr. Inners was suffering, leading medical investigators to focus their attention on York Hospital and the Milton S. Hershey Medical Center at Penn State. Following lawsuits have focused on the manufacturer, first and foremost, hospitals and other facilities were also included in the litigation.

More complaints are registered and lawsuits filed every month. Once this movement reaches critical mass the potential for broader legal action will become clear.

If heater-cooler litigation follows similar medical device lawsuits, it’s very likely to see plaintiffs come together to consolidate their complaints against LivaNova and Sorin.

Damages awarded against LivaNova

Because the litigation is so recent, cases brought against LivaNova/Sorin as well as the healthcare facilities in using contaminated devices have not yet reached a tangible verdict or settlement.

With more than 500,000 patients in the U.S. undergoing open heart surgery in that time, heater-cooler litigation is growing. It’s only a matter of time before financial damages are refunded to patients who have suffered as a result of a contaminated device.

Whether this occurs in or out of court will come down to how aggressively LivaNova defends its equipment. With the groundswell of support for patients and government agency warnings already in place, it is recommended that potential plaintiffs evaluate their case with a legal expert.

Am I eligible to file a claim against LivaNova?

There is enough evidence about the dangers of LivaNova’s Heater-Cooler to suggest that plaintiffs can argue their related injuries were caused by the device.

Patients should speak to an attorney with expertise in this area to talk about their options for legal action. For help finding a lawyer who can help you with a LivaNova Heater-Cooler injury, call (914) 200-0013 or request a case evaluation online.

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